Choking on/Ingestion of Car Seat Foam

The Office of Defects Investigation (ODI) opened Preliminary Evaluation (PE21-014) after receiving four complaints from two consumers and identifying Early Warning Reporting (EWR) Death & Injury (D&I) claims alleging injuries involving production year 2018 Cybex Sirona M car (child) seats. According to the reports, child occupants were able to access a foam material, used in the seat headrest, via an opening in its covering material. When doing so, the child subsequently places foam in their mouths thereby resulting in coughing, gagging, vomiting, or passed by means of bowel movements. No severe injuries are alleged in any of these reports. On August 9, 2021 ODI sent an Information Request (IR) letter to Cybex Sirona M distributor Columbus Trading-Partners (CTP) USA Inc. requesting information related to the subject seat. On September 20, 2021, CTP responded with the requested data and provided their position that the concern did not represent a substantial hazard to children. CTP stated that although they were aware of children having picked small pieces of foam from the subject child seat and ingesting it, they were not aware of any claims of serious injury or death. CTP also stated that after learning of the claims of children having access to and picking off pieces of headrest foam, they made a change in production on August 31, 2018 that would prevent the problem from occurring. CTP claims they have not received any complaints on seats manufactured after that date. Following a review of the IR response data and related precedent recalls, ODI conducted multiple meetings with CTP to explain the agency concerns. With this information CTP decided to submit a voluntary safety recall to remedy the subject child seats manufactured prior to August 31, 2018. On April 20, 2022 recall 22C-001 posted recalling certain Cybex Sirona M Convertible Child Car Seat, model numbers 518000385, 518002153, 518000387, 518002145, 518002149, 518002151, and 519000211, manufactured prior